Therapeutic Oral Device for Sleep Apnea

ABSTRACT

The present disclosure provides generally for a therapeutic oral device for sleep apnea and associated methods for using the device. According to the present disclosure, the device may comprise a hard palate portion, mouth guard portion, and a tongue retainer portion. The hard palate portion may comprise one or more materials. The hard palate portion may also comprise a composite of materials, including but not limited to embedded materials. The mouth guard portion may comprise one or more components that provide stability and maintain the position of the therapeutic oral device within the mouth. The tongue retainer portion may comprise an airway and a predetermined length. A method of use may comprise the utilization of one or more incremental oral devices to overcome a gag reflex. When the oral device is formed from a mold, the mouth guard portion and the hard palate portion may be custom fit to the dimensions of the intended mouth.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to and the full benefit of U.S. Provisional Patent Application Ser. No. 63/139,051 (filed Jan. 19, 2021, and titled “THERAPEUTIC ORAL DEVICE FOR SLEEP APNEA”), the entire contents of which are incorporated in this application by reference.

BACKGROUND

Sleep apnea is a sleeping disorder in which the sleeper's breathing is stopped repeatedly throughout the night. The disorder may cause snoring, restless sleep, difficulty falling asleep or insomnia, excessive sleepiness throughout the day, and more. A number of factors may cause or exacerbate sleep apnea, such as being obese, having a large neck circumference or narrow air passageways, being male, aging, using sedatives, alcohol, or narcotics, and smoking.

There are three types of sleep apnea: obstructive, central, and complex. Obstructive sleep apnea is the most common type and occurs when the throat muscles relax, narrowing the passageway for air to enter or leave. This lack of oxygen flow alerts the brain and wakes up the sleeper, so that breathing may continue as normal. Although the wake often goes unnoticed by the sleeper because it is so brief, this adds to the restlessness and sleepiness symptoms of the sleeper. Central sleep apnea occurs when the brain fails to transmit signals to the breathing muscles. So rather than a physical obstruction preventing someone from breathing, the sleeper simply makes no effort to breathe and may awaken with shortness of breath. Complex sleep apnea is a combination of obstructive and central.

In addition to the many symptoms of sleep apnea, there may also be long term complications that arise as a result of the disorder. Extreme fatigue may occur, and may not only consist of drowsiness, but may also affect being able to concentrate, which may affect work performance, increase the risk of workplace or motor vehicle accidents, or cause drastic mood changes. Due to the sudden drops in oxygen levels, the heart may have to work harder than normal, which may increase the chance of high blood pressure, stroke, heart attacks, and more. Those with sleep apnea have an increased risk of developing type 2 diabetes. Additionally, sleep apnea may cause complications with standard medications or medical procedures, including surgeries.

Many treatments, devices, and even surgeries have been developed over the years to remedy sleep apnea, though each comes with its unique pros and cons. One of the most commonly used devices is the continuous positive airways pressure (CPAP). The CPAP machine requires the sleeper to wear a mask over his nose and mouth, which delivers air at a greater pressure than the surrounding air. This higher air pressure helps the airways stay open, preventing sleep apnea. CPAP machines, however, may be uncomfortable for the wearer, cause claustrophobia or anxiety, and increase the likelihood of dry mouth, nose bleeds, and nasal congestion. CPAP machines cost anywhere from $500-3000, require a prescription, and may not be covered by health insurance.

Other treatments may include wearing an oral appliance, such as a mouthguard or orthodontic retainer, which places pressure on the tongue, nerve stimulation, which sends precise stimuli to nerves in the airway, and nutrition or exercise therapies. Surgery may also work in some instances. This treatment type is most effective for children who get large adenoids or tonsils removed. For adults, it may be difficult to pinpoint what exactly is causing the sleep apnea. Some adult surgical procedures may consist of removing tissue through uvulopalatopharyngoplasty, shrinking tissue with radiofrequency ablation, repositioning the jaw, or implanting rods. Although these procedures may be successful for some, the CPAP machine is still the recommended method of treatment by most physicians.

SUMMARY OF THE DISCLOSURE

What is needed is a convenient and comfortable way to treat sleep apnea that is accessible, budget-friendly, and does not cause other health issues. A mechanical, removeable oral appliance removes electrical requirements and increases design simplicity. An oral appliance that mimics the basic form of a mouth guard possesses a familiarity through association that enables the user to quickly discern its functionality. The compact nature of an oral appliance that resembles a mouth guard allows for transportability and compact storage. The removeable aspect of the oral appliance avoids issues of prolonged wear such as tissue necrosis and inflammation.

The present disclosure provides generally for a therapeutic oral device for sleep apnea. According to the present disclosure, the device may comprise a hard palate portion, mouth guard portion, and a tongue retainer portion. In some embodiments, the hard palate portion may comprise one or more materials. In some implementations, the hard palate portion may also comprise a composite of materials, including but not limited to embedded materials. In some aspects, the mouth guard portion may comprise one or more components that provide stability and maintain the position of the therapeutic oral device within the mouth. In some embodiments, the tongue retainer portion may comprise an airway and a predetermined length. In some implementations, the method may comprise one or more incremental oral devices to overcome a gag reflex. When the oral device is formed from a mold, the mouth guard portion and the hard palate portion may be custom fit to the dimensions of the intended mouth.

The present disclosure relates to a therapeutic oral appliance that may include a mouth guard portion, where the mouth guard portion may be configured to at least partially interface with one or more teeth of a user; a hard palate portion configured to at least partially interface with a hard palate of a mouth of the user, where the hard palate portion extends upward from the mouth guard portion; a tongue retainer portion, where the tongue retainer portion extends from the hard palate portion into at least a portion of a throat of the user, where the tongue retainer portion may comprise an upper surface, a lower surface, and a longitudinal length; and an airway, where the airway may comprise one or more recesses within at least one of the upper surface of the tongue retainer portion and the lower surface of the tongue retainer portion, where the airway extends along at least a portion of the longitudinal length of the tongue retainer portion.

In some embodiments, the mouth guard portion may comprise at least one safety mechanism. In some implementations, the tongue retainer portion may be fixed to a distal end of the hard palate portion. In some aspects, the longitudinal length of the tongue retainer portion may be adjustable. In some embodiments, the mouth guard portion may comprise at least one external attachment configured to interface with at least one supplemental device. In some implementations, the at least one external attachment may comprise at least one aperture.

In some aspects, the at least one supplemental device may comprise a tube. In some embodiments, the mouth guard portion may comprise a universal fit that may be used by a generic user. In some implementations, the therapeutic oral appliance may be configured to interface with at least one wearable device. In some aspects, the at least one wearable device may comprise a smart watch. In some embodiments, the mouth guard portion may be configured to interface with one or more dental fixtures. In some implementations, the one or more dental fixtures may comprise braces.

In some aspects, the therapeutic oral appliance further may comprise one or more sensors. In some embodiments, the one or more sensors may comprise at least one of an accelerometer, a heart rate monitor, a pulse oximeter, and a capnograph. In some implementations, the therapeutic oral appliance may be configured to interface with at least one external device. In some aspects, the at least one external device may comprise at one of a smartphone, a desktop computer, a laptop computer, a tablet, and a medical apparatus. In some embodiments, the mouth guard portion may comprise at least one wire. In some implementations, the mouth guard portion may comprise an at least partially customized fit for a specific user. In some aspects, the mouth guard portion may be adjustable. In some embodiments, the hard palate portion extends upward from the mouth guard portion to a point of central convergence.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings that are incorporated in and constitute a part of this specification illustrate several embodiments of the disclosure and, together with the description, serve to explain the principles of the disclosure:

FIG. 1A illustrates a top-down view of an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 1B illustrates a side view of an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 1C illustrates a perspective view of an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 2A illustrates an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 2B illustrates a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 3A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion, according to some embodiments of the present disclosure.

FIG. 3B illustrates an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 4A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion, according to some embodiments of the present disclosure.

FIG. 4B illustrates an exemplary a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 5A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion, according to some embodiments of the present disclosure.

FIG. 5B illustrates an exemplary a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 6A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion, according to some embodiments of the present disclosure.

FIG. 6B illustrates an exemplary a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 7A illustrates an exemplary therapeutic oral appliance comprising a tongue retainer portion, according to some embodiments of the present disclosure.

FIG. 7B illustrates an exemplary cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 8A illustrates a front view of an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 8B illustrates a rear view of an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 9 illustrates a mouth wearing an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 10 illustrates an exemplary therapeutic oral appliance with a safety mechanism, according to some embodiments of the present disclosure.

FIG. 11A illustrates a side view of an exemplary therapeutic oral appliance with a mouth guard portion attachment, according to some embodiments of the present disclosure.

FIG. 11B illustrates a perspective view of an exemplary therapeutic oral appliance with a mouth guard portion attachment, according to some embodiments of the present disclosure.

FIG. 12A illustrates a side view of an exemplary therapeutic oral appliance interfacing with an external device, according to some embodiments of the present disclosure.

FIG. 12B illustrates a side view of an exemplary therapeutic oral appliance interfacing with an external device, according to some embodiments of the present disclosure.

FIG. 12C illustrates a perspective view of an exemplary therapeutic oral appliance interfacing with an external device, according to some embodiments of the present disclosure.

FIG. 13A illustrates a side view of an exemplary therapeutic oral appliance with a mouth guard portion attachment, according to some embodiments of the present disclosure.

FIG. 13B illustrates a perspective view of an exemplary therapeutic oral appliance with a mouth guard portion attachment, according to some embodiments of the present disclosure.

FIG. 14A illustrates a side view of an exemplary therapeutic oral appliance with a mouth guard portion attachment, according to some embodiments of the present disclosure.

FIG. 14B illustrates a perspective view of an exemplary therapeutic oral appliance with a mouth guard portion attachment, according to some embodiments of the present disclosure.

FIG. 15A illustrates a side view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion, according to some embodiments of the present disclosure.

FIG. 15B illustrates a top-down view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion, according to some embodiments of the present disclosure.

FIG. 16A illustrates a side view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion, according to some embodiments of the present disclosure.

FIG. 16B illustrates a top-down view of an exemplary therapeutic oral appliance with an adjustable tongue retainer portion, according to some embodiments of the present disclosure.

FIG. 17 illustrates an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 18 illustrates an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 19 illustrates an exemplary adjustable therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 20 illustrates an exemplary therapeutic oral appliance attachable to dental fixtures, according to some embodiments of the present disclosure.

FIG. 21 illustrates an exemplary therapeutic oral appliance with wireless data transmission capabilities, according to some embodiments of the present disclosure.

FIG. 22A illustrates a process of forming an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 22B illustrates a process of forming an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

FIG. 23 illustrates a process of forming an exemplary therapeutic oral appliance, according to some embodiments of the present disclosure.

DETAILED DESCRIPTION

In the following sections, detailed descriptions of examples and methods of the disclosure will be given. The description of both preferred and alternative examples, though thorough, are exemplary only, and it is understood to those skilled in the art that variations, modifications, and alterations may be apparent. It is therefore to be understood that the examples do not limit the broadness of the aspects of the underlying disclosure as defined by the claims.

Glossary

-   -   Therapeutic oral appliance: as used herein refers to a device         inserted into the mouth that assists in maintaining an         unobstructed airway for therapeutic purposes. In some aspects, a         therapeutic oral appliance may limit risks associated with sleep         apnea by limiting movement of the tongue.     -   Tongue retainer portion: as used herein refers to a portion of         the therapeutic oral appliance that limits backward movement of         the tongue when the therapeutic oral appliance is worn. In some         embodiments, a tongue retainer portion may comprise airways that         may prevent occlusion of the throat, allowing for unobstructed         breathing.     -   Hard palate portion: as used herein refers to a portion of the         therapeutic oral appliance that is configured to at least         partially interface with the hard palate within the mouth of a         user.     -   Mouth guard portion: as used herein refers to a portion that         fits to or over at least a portion of one or more teeth. In some         aspects, a mouth guard portion may be customized to fit a user's         teeth, such as through use of a dental mold. A mouth guard         portion may comprise an at least partially customized fit for a         specific user. In some embodiments, a mouth guard portion may         have a more universal fit that may be used by a generic user         without requiring a custom fitting.     -   OSA: as used herein refers to obstructive sleep apnea.

Referring now to FIGS. 1A-1C, an exemplary therapeutic oral appliance 100 is illustrated. In some embodiments, the therapeutic oral appliance 100 may comprise a tongue retainer portion 110. In some implementations, the tongue retainer portion 110 may comprise one or more predetermined lengths. This may allow the user to gradually become accustomed to the presence of the tongue retainer portion 110 within at least a portion of the throat. Gradual introduction may allow for the suppression of the gag reflex, which may occur as the length of the tongue retainer portion 110 enters the throat. In some aspects, the tongue retainer portion 110 may comprise an upper surface, a lower surface, and a longitudinal length.

In some embodiments, the therapeutic oral appliance 100 may be utilized to relieve airway obstruction from a one or more sources. As an illustrative example, the therapeutic oral appliance 100 may directly relieve obstruction caused by obstruction at the back or base of the tongue, uvula, and soft palate. The therapeutic oral appliance 100 may partially relieve obstruction that is caused by issues below the epiglottis such as hypopharyngeal issues, vocal cord folds and arytenoids, anterior-posterior soft palate collapse, lateral soft palate collapse, complete concentric collapse, epiglottic and tonsillar collapse. The therapeutic oral appliance 100 may address a plurality of issues of obstruction simultaneously through prescribed therapeutic use.

In some implementations, the therapeutic oral appliance 100 may contribute to partial relief of obstruction by improving overall muscle tone of the oropharynx. This improvement may result as muscles resist and gain tone by resisting the therapeutic oral appliance 100. In some aspects, an airway 115 may provide airflow from the mouth to the soft palate. This may improve breathing and decrease airway obstruction.

In some embodiments, the material of the therapeutic oral appliance 100 may comprise materials that are sufficiently durable and chemical resistant to sanitize the therapeutic oral appliance 100 on a daily basis by chemical (e.g., mouth wash or alcohols) means or physical means (e.g., steam sterilization), as non-limiting examples. In some implementations, the removeable aspect of the therapeutic oral appliance 100 may allow the user to clean and sanitize the therapeutic oral appliance 100 frequently. This may facilitate accessible cleaning that may reduce the possibility of tissue necrosis and infection, as a non-limiting list.

In some implementations, the therapeutic oral appliance 100 may comprise a hard palate portion 130. In some embodiments, the mating connected by symmetric surfaces between the hard palate and the hard palate portion 130 may improve the stability of the therapeutic oral appliance 100 within the oral cavity. In some aspects, the therapeutic oral appliance 100 may comprise a mouth guard portion 120. In some additional aspects, the hard palate portion 130 may extend upward from the mouth guard portion 120 to a central point of convergence.

In some embodiments, the mouth guard portion 120 may comprise a composite of materials. This may prevent fracture and fragment wear that could cause worn parts of the therapeutic oral appliance 100 to be swallowed. In some implementations, the substrate material may be embedded within the primary material.

As an example, a hard plastic plate may be embedded in the medium of ethylene-vinyl acetate (EVA), or an elastomeric polymer, as the softer plastic cures within the teeth mold. In some aspects, the embedded substrate may be fragmentary. As another example, an EVA material may have plates of harder plastic embedded in the regions over the rear molars to reduce wear from teeth grinding. In some embodiments, the therapeutic oral appliance 100 may comprise a coated aspect. As an example, the therapeutic oral appliance 100 may be coated in a hardened plastic film that reduces torsional fatigue within the structure of the therapeutic oral appliance 100.

The mouth guard portion 120 may be configured to at least partially interface with one or more teeth of a user. This interface may maintain the position of the therapeutic oral appliance 100 in the mouth and prevent ingestion of the therapeutic oral appliance 100. In some aspects, the therapeutic oral appliance 100 may comprise a hard palate portion 130. The hard palate portion 130 may interface with the hard palate within the mouth. In some implementations, the mouth guard portion 120 and the hard palate portion 130 may reduce point pressure by spreading the retaining force for the therapeutic oral appliance 100 across a larger surface area.

The mouth guard portion 120 may provide protection to the soft sensitive tissue of the oral pharynx. A mouth guard portion 120 may protect the parts of the hard palate, soft palate, and oral pharynx from pressure points, as a non-limiting list. The pressure may originate from the oral airway. The mouth guard portion 120 may prevent pain and possible tissue necrosis by preventing these pressure points. In some aspects, the mouth guard portion 120 may extend to cover the hard and soft palate to protect sensitive tissues. This protection may assist in pushing the oral airway away from the oropharynx. In some embodiments, moving the oral airway away from the oropharynx may decrease the gag reflex.

In some implementations, the level of customization of the therapeutic oral appliance 100 may vary. As an illustrative example, a user may receive a dental impression in a dentist's office that provides a high-fidelity model of the unique aspects of the user's mouth. This impression may be formed via physical or digital dental impression. This impression may become the casting for the therapeutic oral appliance 100. This high level of customization may allow the fit of the therapeutic oral appliance 100 to match the form of the hard palate and teeth with precision. It may also improve the overall comfort and performance of the oral device. The oral device can be customized to fit each user's unique dentition, maxillary or dental arch, palatal arch or vault, and palatal mucosa and rugae, thus making the least intrusive oral airway size and path for maximal comfort.

As another illustrative example, a user may purchase a therapeutic oral appliance 100 remotely. The therapeutic oral appliance 100 may be delivered as a generic casting of a therapeutic oral appliance 100. The generic mold may fit most mouths in a loose composition. The generic casting may then become pliable after boiling it in water. This pliability may allow the user to press the therapeutic oral appliance 100 firmly into their mouth to allow the therapeutic oral appliance 100 to harden in the shape of the user's mouth. This formed fit may provide sufficient stability, without requiring a dentist visit.

In some embodiments, the therapeutic oral appliance 100 may interface with the oral cavity. The quality of the interface may contribute to safety, comfort, and effectiveness as a therapeutic device, as a non-limiting list. In some implementations, the removeable aspect of the therapeutic oral appliance 100 may also provide opportunity for frequent sanitation. This may prevent infection, inflammation, and tissue necrosis, as non-limiting examples.

In some embodiments, the mouth guard portion 120 may interface with the teeth. This interface may maintain the position of the therapeutic oral appliance 100 in the mouth and prevent ingestion of the therapeutic oral appliance 100. In some aspects, the therapeutic oral appliance 100 may comprise a hard palate portion 130. The mouth guard portion 120 and the hard palate portion 130 may reduce the probability of subconscious rejection of the therapeutic oral appliance 100 by spitting it out. The custom fit of the therapeutic oral appliance 100 may reduce this probability by increasing comfort. In some aspects, the interface between the therapeutic oral appliance 100 and the oral cavity may assist in alignment of the tongue retainer portion 110 within the throat. Unsecured movement of the tongue retainer portion 110 may result in triggering the gag reflex or choking.

In some embodiments, the tongue retainer portion 110 may be fixed to and extend from a distal end of the hard palate portion 130 into at least a portion of the throat sufficient to reduce movement of the tongue. In some implementations, the tongue retainer portion 110 may be trimmable for preferential comfort and fit within the throat, as non-limiting examples. In some aspects, the tongue retainer portion 110 may prevent the tongue from falling back and touching the soft palate, which may otherwise create airway obstruction. In some embodiments, the tongue retainer portion 110 may comprise an airway 115 that ensures airflow when the tongue retainer portion 110 occupies the throat.

In some aspects, the tongue retainer portion 110 may comprise an airway 115. In some implementations, the airway 115 may comprise one or more recesses or slots within the upper and/or lower surface of the tongue retainer portion 110 that extend along at least a portion of the longitudinal length of the tongue retainer portion 110, thereby forming one or more channels or grooves. In some embodiments, airway 115 channels may provide an airway to allow air flow. In some implementations, the airway 115 may follow the natural anatomical airway passage of the user. This may decrease the chance of inadvertent airway obstruction by the therapeutic oral appliance 100. The conformity to the natural anatomy of the oral cavity may result from the custom fit of the therapeutic oral appliance 100.

Referring now to FIG. 2A, an exemplary therapeutic oral appliance 200 is illustrated. Referring now to FIG. 2B, a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 200 is illustrated. In some embodiments, the therapeutic oral appliance 200 may comprise a hard palate portion 230. In some implementations, the therapeutic oral appliance 200 may comprise a mouth guard portion 220. In some aspects, the hard palate portion 230 may extend upward from the mouth guard portion 220 to a central point of convergence.

In some embodiments, the hard palate portion 230 may interface with the hard palate 260. In some aspects, the surface of the hard palate portion 230 may mirror the geometry of the hard palate 260 to provide a custom fit. In some embodiments, the hard palate portion 230 may comprise identical geometry to the hard palate 260 by being cured in a mold formed from an impression of the user's oral cavity. In some implementations, this mold may be a standard mold used in creating denture impressions.

In some implementations, the distal end of the therapeutic oral appliance 200 may align with the beginning of the soft palate 270 within the oral cavity. This may prevent damage from continual applied force on the soft palate 270. In some implementations, the mouth guard portion 220 may interface with the teeth 250. In some aspects, the interaction between the guard portion 220 and the teeth 250 may operate as a mated interface that is formed by curing the resin for the therapeutic oral appliance 200 within a casting made from an impression of the user's teeth 250.

A patient may wear a therapeutic oral appliance 200 without tongue retainer portion to begin the incremental process to suppress the gag reflex. Wearing a therapeutic oral appliance 200 may be uncomfortable at first, particularly for those who are unaccustomed to wearing oral appliances. A patient may get used to the therapeutic oral appliance 200 by wearing it for a few hours and then overnight, as a way to build up to the gag reflex suppression process with the tongue retainer portion.

In some embodiments, the mouth guard portion 220 may comprise a generic cast that, upon inducing heat to increase malleability, may be formed to the shape of the intended teeth 250. This may provide greater comfort when wearing the therapeutic oral appliance 200. A formed therapeutic oral appliance 200 may prevent unconscious reject from the mouth. For example, a user may unconsciously spit out the therapeutic oral appliance while sleeping unless the therapeutic oral appliance 200 is homogeneous with the structure of the oral cavity.

In some aspects, the mouth guard portion 220 may comprise a cavity designed to enclose a plurality of teeth 250 simultaneously. The thickness of the outside edge of the mouth guard portion 220 may be of minimal thickness to ensure an unobstructive fit within the oral cavity. In some embodiments, a minimal thickness may increase the comfort of the therapeutic oral appliance 200 and the effectiveness of therapeutic utilization by avoiding subconscious rejection, as non-limiting examples.

Referring now to FIG. 3A, an exemplary therapeutic oral appliance 300 comprising a tongue retainer portion 310 is illustrated. Referring now to FIG. 3B, an exemplary a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 300 is illustrated. In some embodiments, the therapeutic oral appliance 300 may comprise a hard palate portion 330. In some implementations, the therapeutic oral appliance 300 may comprise a mouth guard portion 320. In some embodiments, the hard palate portion 330 may interface with the hard palate 360.

In some implementations, the tongue retainer portion 310 may align with the soft palate 370. In some embodiments, the tongue retainer portion 310 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the therapeutic oral appliance 300 may enter the throat 380 via the tongue retainer portion 310. In some implementations, the therapeutic oral appliance 300 may comprise a tongue retainer portion 310 of a plurality of predetermined lengths. This may allow the user to gradually become accustomed to the presence of the tongue retainer portion 310 within the throat 380. This may train the gag reflex to refrain from engaging the tongue retainer portion 310 sufficient to allow the user to insert the therapeutic oral appliance 300 daily. In some embodiments, the tongue retainer portion 310 may be fixed to a distal end of the hard palate portion 330.

In some embodiments, the therapeutic oral appliance 300 may interface with the tongue 340. In some aspects, the tongue retainer portion 310 may direct the tongue 340 through the physical presence of the tongue retainer portion 310. In some embodiments, the tongue retainer portion 310 may restrain the tongue 340 sufficient to facilitate unobstructed breathing.

For example, a person in a coma may need a clear airway to receive sufficient oxygen. In an unconscious state, the tongue 340 may otherwise reduce or impair the user's airway. In some implementations, the mouth guard portion 320 may be configured to at least partially interface with one or more teeth 350. This may prevent the therapeutic oral appliance 300 from dislodgement and potential ingestion.

Referring now to FIG. 4A, an exemplary therapeutic oral appliance 400 comprising a tongue retainer portion 410 is illustrated. Referring now to FIG. 4B, an exemplary a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 400 is illustrated. In some embodiments, the therapeutic oral appliance 400 may comprise a hard palate portion 430. In some implementations, the therapeutic oral appliance 400 may comprise a mouth guard portion 420. In some aspects, the hard palate portion 430 may extend upward from the mouth guard portion 420 to a central point of convergence.

In some embodiments, the hard palate portion 430 may interface with the hard palate 460. In some implementations, the tongue retainer portion 410 may align with the soft palate 470. In some embodiments, the tongue retainer portion 410 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the therapeutic oral appliance 400 may enter the throat 480. In some implementations, the tongue retainer portion 410 may enter the throat incrementally to avoid triggering a gag reflex. In some embodiments, the tongue retainer portion 410 may be fixed to a distal end of the hard palate portion 430.

A gag reflex is a contraction of the throat that occurs when an object makes contact with the back of the tongue 440 or throat 480. This gag reflex may be overcome through incremental introduction of the tongue retainer portion 410 into the throat 480. In some aspects, this may be introduced by wearing a therapeutic oral appliance 400 with an incremental increase in tongue retainer portion length 410 for a predetermined time.

The length of the tongue retainer portion 410 may be sufficiently short to prevent the grasping of the tongue retainer portion 410 by the throat 480 via throat contraction caused by the gag reflex. The length of the tongue retainer portion 410 may be sufficiently short to prevent irregular swallowing due to the throat exerting a downward force on the therapeutic oral appliance 400 by grasping the end of the tongue retainer portion 410 during throat contraction.

In some embodiments, the therapeutic oral appliance 400 may interface with the tongue 440. In some embodiments, the tongue retainer portion 410 may restrain the tongue 440 sufficiently to facilitate unobstructed breathing. In some implementations, the mouth guard portion 420 may be configured to at least partially interface with one or more teeth 450. In some aspects, the mouth guard portion 420 may secure the therapeutic oral appliance 400 within the oral cavity. This may prevent ingestion of the therapeutic oral appliance 400.

Referring now to FIG. 5A, an exemplary therapeutic oral appliance 500 comprising a tongue retainer portion 510 is illustrated. Referring now to FIG. 5B, an exemplary a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 500 is illustrated. In some embodiments, the therapeutic oral appliance 500 may comprise a hard palate portion 530. In some embodiments, the hard palate portion 530 may interface with the hard palate 560. The interface between the hard palate 560 and the hard palate portion 530 may provide stability that reduces movement of the tongue retainer portion 510 within the throat 580.

In some implementations, the therapeutic oral appliance 500 may comprise a mouth guard portion 520. In some implementations, the hard palate portion 530 may extend upward from the mouth guard portion 520 to a central point of convergence. In some implementations, the mouth guard portion 520 may be configured to at least partially interface with one or more teeth 550. In some aspects, the mouth guard portion 520 may provide a generic fit to the teeth 550 with limited malleable properties. This generic tooth form may provide sufficient stability to prevent ingestion of the therapeutic oral appliance 500.

In some implementations, the tongue retainer portion 510 may align with the soft palate 570. In some embodiments, the tongue retainer portion 510 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the therapeutic oral appliance 500 may enter the throat 580. In some implementations, the user may modify the length of the tongue retainer portion 510. In some aspects, the tongue retainer portion 510 may be shortened by severing the tongue retainer portion 510 with scissors to the desired length. This may allow a user to customize the length of the tongue retainer portion 510. Shortening the tongue retainer portion 510 may be necessary if the tongue retainer portion 510 extends into the throat 580 sufficient to trigger the gag reflex. In some embodiments, the therapeutic oral appliance 500 may interface with the tongue 540.

Referring now to FIG. 6A, an exemplary therapeutic oral appliance 600 comprising a tongue retainer portion 610 is illustrated. Referring now to FIG. 6B, an exemplary a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 600 is illustrated. In some embodiments, the therapeutic oral appliance 600 may comprise a hard palate portion 630. In some implementations, the therapeutic oral appliance 600 may comprise a mouth guard portion 620. In some aspects, the hard palate portion 630 may extend upward from the mouth guard portion 620 to a central point of convergence. In some implementations, the mouth guard portion 620 may be configured to at least partially interface with one or more teeth 650.

In some embodiments, the hard palate portion 630 may interface with the hard palate 660. In some implementations, the tongue retainer portion 610 may align with the soft palate 670. In some embodiments, the tongue retainer portion 610 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the tongue retainer portion 610 may be fixed to a distal end of the hard palate portion 630 and encroach into the throat 680. In some implementations, the tongue retainer portion 610 may increase in length incrementally.

As an illustrative example, a user may, upon ordering the therapeutic oral appliance, receive a plurality of therapeutic oral appliances comprising therapeutic oral appliances with incremental tongue retainer portions, such as described in FIGS. 2A-6A. In preparation for using the therapeutic capabilities of the therapeutic oral appliance, the user may use a therapeutic oral appliance with incrementally longer tongue retainer portions until snoring is effectively prevented. A user may wear each size for a few days to a few weeks each, depending on the comfort level of each therapeutic oral appliance. The user may use the therapeutic oral appliance daily while sleeping to acclimate the throat to the tongue retainer portion and overcome the gag reflex.

Dependent upon individual anatomy, the user may discover that an intermediary length of the tongue retainer portion is of sufficient length for therapeutic purposes, where the user may not benefit from an incrementally longer tongue retainer portion. In some embodiments, the user may incrementally increase the length of the tongue retainer portion 610 until the length is sufficient to relieve obstruction but remain sufficiently comfortable for use while sleeping. In some aspects, the user may discover a need to trim the length of the tongue retainer portion 610 of the therapeutic oral appliance to achieve a desired length that is between the incremental tongue retainer portions. In some implementations, the length of the tongue retainer portion 610 may remain shorter than the distance to the epiglottis to ensure swallowing remains possible.

Referring now to FIG. 7A, an exemplary therapeutic oral appliance 700 comprising a tongue retainer portion 710 is illustrated, wherein the therapeutic oral appliance 700 is fitted for a child. Referring now to FIG. 7B, an exemplary a cross-sectional view of an oral cavity with an exemplary therapeutic oral appliance 700 is illustrated. In some embodiments, the therapeutic oral appliance 700 may comprise a hard palate portion 730. In some implementations, the therapeutic oral appliance 700 may comprise a mouth guard portion 720. In some aspects, the hard palate portion 730 may extend upward from the mouth guard portion 720 to a central point of convergence.

In some embodiments, the hard palate portion 730 may interface with the hard palate 760. In some implementations, the tongue retainer portion 710 may align with the soft palate 770. In some embodiments, the tongue retainer portion 710 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the therapeutic oral appliance 700 may enter the throat 780. In some embodiments, the therapeutic oral appliance 700 may interface with the tongue 740. In some implementations, the mouth guard portion 720 may be configured to at least partially interface with one or more teeth 750.

For smaller mouths, such as with children, incremental increases in tongue retainer portions 710 may be smaller to allow for a more refined fit. Smaller size increases may allow for easier transition with increased likelihood that the gag reflex suppression may occur without issue. Smaller mouths may require shorter tongue retainer portions 710. In some aspects, the incremental sizes of tongue retainer portions 710 may depend on predefined factors, such as strength of gag reflex, mouth size, user preference, practitioner recommendations, or level of customization. For example, where the therapeutic oral appliance is prescribed by a practitioner, the increments may be more customized than an over-the-counter version of a therapeutic oral appliance.

Referring now to FIGS. 8A-8B, a front view of an exemplary therapeutic oral appliance 800 is illustrated. In some embodiments, the tongue retainer portion 810 of the therapeutic oral appliance 800 may comprise one or more uniform recesses or slots that span the longitudinal length of the tongue retainer portion 810 to create an airway 815. In some implementations, the airway 815 may comprise uniform indentations along the sidewall of the tongue retainer portion 810. In some aspects, the airway 815 may comprise air flow pathways that are parallel to the direction of the throat.

For example, the tongue retainer portion 810 may comprise one or more airway 815 tubes that continue for the longitudinal length of the tongue retainer portion 810. This may be useful if the throat is inflamed or otherwise restricted so as to render embedded channels within the walls of the tongue retainer portion 810 ineffective. In some embodiments, the airway 815 may comprise an integrated tube that runs through the center of the tongue retainer portion 810. This may reduce the required insertion diameter and prevent obstruction by utilizing existing material that extends the length of the therapeutic oral appliance 800.

Referring now to FIG. 9, a mouth wearing an exemplary therapeutic oral appliance 900 is illustrated. In some embodiments, the mouth guard portion 920 may be configured to at least partially interface with one or more teeth 950 in a form fit. The therapeutic oral appliance 900 may fit similarly to a sport mouth guard, teeth whitening tray, incremental braces systems, or teeth grinding protectors, as non-limiting examples. In some aspects, a therapeutic oral appliance 900 may fit over dentures. In some embodiments, a therapeutic oral appliance 900 may fit over gums for user's who may remove their dentures at night.

Referring now to FIG. 10, an exemplary therapeutic oral appliance 1000 with a safety mechanism is illustrated. In some embodiments, the therapeutic oral appliance 1000 may comprise at least one safety mechanism 1005. In some implementations, the safety mechanism 1005 may extend the entirety of the length of the therapeutic oral appliance 1000. In some aspects, this may prevent the ingestion of a portion of the therapeutic oral appliance 1000 that may break off from the therapeutic oral appliance 1000. This may be possible after prolonged use creates fatigue within the therapeutic oral appliance 1000 that creates structural instability within the therapeutic oral appliance 1000.

Referring now to FIGS. 11A-11B, an exemplary therapeutic oral appliance 1100 with a mouth guard portion 1120 attachment is illustrated. In some embodiments, the mouth guard portion 1120 may comprise at least one external attachment. In some aspects, the external attachment may maintain a partially opened state for the mouth. In some implementations, the external attachment may be configured to interface with at least one supplemental device. The external attachment may comprise at least one aperture or opening that allows for the insertion of a variety of supplemental devices in the form of tubes into the oral cavity.

As an example, an anesthesiologist may insert tubes to regulate sedation during surgery. This opening in the external attachment, with support from the hard palate portion 1130, may provide stability that allows the tube to remain in a fixed state. A source of humidified air or oxygen may be diffused near the oral cavity to provide humidification. This may assist in preventing dryness in the mouth and oropharynx. The reduced dryness may provide increased user comfort. As another example, a feeding tube may interface with the external attachment to provide nutrition to a user in a coma. Supplemental tubes may also sustain health for users with a variety of health challenges.

As an illustrative example, a tube opening may provide access to the oral cavity while a user undergoes an epileptic seizure. The tongue retainer portion 1110 may assist in stabilizing the tongue and maintaining an unobstructed airway. The tube opening may assist in dampening muscular contractions within the jaw that may otherwise harm the user during the epileptic seizure. The tube opening may also maintain an orifice for the duration of the episode in case vomiting occurs.

Physical disabilities may also necessitate the utilization of supplemental tubes for sustenance. For example, a user with cerebral palsy may struggle with aspiration due to muscle weakness. This may necessitate a breathing tube. Due to other muscular atrophy and fatigue, a feeding tube may also be employed to ensure adequate nutrition. A therapeutic oral appliance 1100 may allow for prolonged use with reduced risk of damage to a user's mouth, throat, respiratory system, and overall health.

Referring now to FIGS. 12A-12B, an exemplary therapeutic oral appliance 1200 with a mouth guard portion 1220 attachment is illustrated. In some embodiments, the mouth guard portion 1220 may comprise at least one external attachment. In some implementations, the mouth guard portion 1220 may interface with at least one supplemental device 1290. In some embodiments, the mouth guard portion 1220 may interface with at least one supplemental device 1290 via the external attachment. In some aspects, the external attachment may maintain a partially opened state for the mouth. In some embodiments, the external attachment may comprise an aperture or opening that allows for the insertion of a variety of supplemental devices 1290 in the form of tubes into the oral cavity.

As an example, an anesthesiologist may insert a tube to regulate sedation during surgery. This opening in the external attachment, with support from the hard palate portion 1230, may provide stability that allows the tube to remain in a fixed state. The opening in the external attachment may comprise a similar diameter to commonly interfaced sedation tubes. A source of humidified air or oxygen may be diffused near the oral cavity to provide humidification. This may assist in preventing dryness in the mouth and oropharynx. The reduced dryness may provide increased user comfort.

Physical disabilities may also necessitate the utilization of supplemental tubes for sustenance. For example, a user with cerebral palsy may struggle with aspiration due to muscle weakness. This may necessitate a breathing tube. Due to other muscular atrophy and fatigue, a feeding tube may also be employed to ensure adequate nutrition. A therapeutic oral appliance 1200 may allow for prolonged use with reduced risk of damage to a user's mouth, throat, respiratory system, and overall health.

Referring now to FIGS. 13A-13B, a side view of exemplary therapeutic oral appliance 1300 with a mouth guard portion attachment is illustrated. In some embodiments, the therapeutic oral appliance 1300 may comprise a mouth guard portion 1320. In some implementations, the mouth guard portion 1320 may comprise an attachment to prevent the grinding of the teeth. In some aspects, the therapeutic oral appliance 1300 may comprise a hard palate portion 1330 that may assist with reducing translational movement caused by teeth grinding. In some implementations, the hard palate portion 1330 may extend upward from the mouth guard portion 1320 to a central point of convergence.

Referring now to FIG. 14A-14B, a side view of exemplary therapeutic oral appliance 1400 with a mouth guard portion attachment is illustrated. In some embodiments, the therapeutic oral appliance 1400 may comprise a mouth guard portion 1420. In some implementations, the mouth guard portion 1420 may comprise an attachment to prevent the grinding of the teeth. In some aspects, the therapeutic oral appliance 1400 may comprise a hard palate portion 1430 that may assist with reducing translational movement caused by teeth grinding. In some embodiments, the hard palate portion 1430 may extend upward from the mouth guard portion 1420 to a central point of convergence.

In some aspects, the therapeutic oral appliance 1400 may interface with the lower jaw via attachment to a lower therapeutic oral appliance 1400. In some embodiments, a therapeutic oral appliance may cover the lower teeth. In some implementations, the therapeutic oral appliance may connect to the therapeutic oral appliance 1400 secured to the upper palate. This may increase comfort and security, as non-limiting attributes. A lower therapeutic oral appliance may decrease the probability of the user spitting out the therapeutic oral appliance 1400.

Referring now to FIGS. 15A-15B, an exemplary therapeutic oral appliance 1500 with an adjustable tongue retainer portion 1510 is illustrated. In some embodiments, the tongue retainer portion 1510 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the tongue retainer portion 1510 may extend into the throat at a variety of lengths that are determined by a plurality of predetermined longitudinal lengths that are adjusted in a region of the therapeutic oral appliance 1500. In some embodiments, the tongue retainer portion 1510 may be fixed to a distal end of the hard palate portion 1530. In some implementations, the tongue retainer portion 1510 may be removed from the therapeutic oral appliance 1500. This may be a helpful state for users who are beginning the acclimation process of the tongue retainer portion 1510 within the throat.

In some embodiments, the adjustable aspect of the tongue retainer portion 1510 may interface with an extrusion connected to the mouth guard portion 1520. In some aspects, the adjustment of the tongue retainer portion 1510 may comprise a mechanism that exerts force on a fixture attached to the therapeutic oral appliance 1500. In some implementations, the hard palate portion 1530 may provide stability as the therapeutic oral appliance 1500 is adjusted within the oral cavity. In some aspects, the tongue retainer portion 1510 may comprise an airway 1515 that extends in conjunction with the extension of the tongue retainer portion 1510.

In some embodiments, the airway 1515 may originate on the top of the mouth guard portion 1520. In some implementations, the airway 1515 and tongue retainer portion 1520 may be molded to follow the contour of the hard palate and soft palate. In some aspects, one or more channels for airway patency are included along the sides of airway 1515. In some embodiments, these channels may begin between the teeth or gums, as non-limiting options, in the case of edentulism, to provide airway patency so the airway 1515 is not occluded by the teeth or lips.

In some embodiments, the airway 1515 and the tongue retainer portion 1520 may comprise a reinforced bridge portion that runs along the midline, near the midline, or parallel to midline of the hard palate and soft palate, as non-limiting alternatives. In some implementations, this reinforced portion may be attached to a flattened section that runs parallel to the hard palate portion 1530. This may provide increased surface area to push and stabilize the tongue and soft palate tissue away from each other to provide an airway 1515. In some aspects, the gap created by the reinforced bridge between the palate and the flattened plane may facilitate air flow. In some embodiments, the parallel planes separated by the reinforced bridge may form the airway 1515.

As an illustrative example, the cross section of this structural design may be similar to an I-beam. The I-beam consists of two horizontal planes, known as flanges, connected by one vertical component, or the web. The shape of the flanges and the web create an “I” cross-section. The flanges correlate to the planes touching the palate on one end and the tongue on the other end.

The web correlates to the reinforced bridge that is the vertical component that connects the two horizontal planes. The space between the flanges created by the web is the channel where the air flow passes. The cross-sectional area for the airway 1515 may be sufficient to prevent increased respiratory effort or increased negative pressure on the lungs.

Referring now to FIG. 16A-16B, an exemplary therapeutic oral appliance 1600 with an adjustable tongue retainer portion 1610 is illustrated. In some embodiments, the tongue retainer portion 1610 may comprise an upper surface, a lower surface, and a longitudinal length. In some aspects, the tongue retainer portion 1610 may extend into the throat at a variety of lengths that are determined by a plurality of predetermined longitudinal lengths that are adjusted in a region of the therapeutic oral appliance 1600. In some implementations, the tongue retainer portion 1610 may be removed from the therapeutic oral appliance 1600.

In some embodiments, the mouthguard portion 1620 may remain fixed while the airway 1615 may be moved and secured at different depths within the throat. In some implementations, the airway 1615 channel may be slid back and forth until the desired depth into the throat is reached. In some aspects, the airway 1615 may be secured into this position by a clamp or another non-limiting securing device.

For example, a client may purchase a single therapeutic oral appliance and, at first, may use the therapeutic oral appliance with an airway that is completely retracted. The client may gradually increase the extension of the airway into the throat until the airway has extended the originally intended distance into the throat.

In some embodiments, the airway 1615 may originate on the top of the mouth guard portion 1620. In some implementations, the airway 1615 and tongue retainer portion 1620 may be molded to follow the contour of the hard palate and soft palate. In some aspects, one or more channels for airway patency are included along the sides of airway 1615. In some embodiments, these channels may begin between the teeth or gums, as non-limiting options, in the case of edentulism, to provide airway patency so the airway 1615 is not occluded by the teeth or lips.

Referring now to FIG. 17, an exemplary therapeutic oral appliance 1700 is illustrated. In some embodiments, the mouth guard portion 1720 may comprise a plurality of components. In some aspects, the mouth guard portion 1720 may comprise a brace with selective teeth caps. For example, at least one flexible wire may prevent slipping by applying a minimal retaining force upon the front teeth. A symmetrical plurality of tooth caps may be attached to the flexible wire and secure the therapeutic oral appliance 1700 by enclosing a plurality of teeth on both sides of the mouth.

In some embodiments, the tooth caps may comprise a generic cast that, upon inducing heat to increase malleability, may be formed to the shape of the intended teeth. In some aspects, the tooth cap may comprise a cavity designed to enclose a plurality of teeth simultaneously. The thickness of the outside edge of the tooth cap may be of minimal thickness to ensure a fit between the teeth enclosed within the tooth cap and those excluded. In some implementations, a mold may provide a mated fit between the hard palate portion 1730 and the hard palate within the oral cavity.

Referring now to FIG. 18, an exemplary therapeutic oral appliance 1800 is illustrated. In some embodiments, the mouth guard portion 1820 may comprise a plurality of components. In some aspects, the mouth guard portion 1820 may comprise a brace with selective teeth caps. In some embodiments, the teeth caps may enclose a plurality of teeth singularly. In some implementations, the mouth guard portion 1820 may allow a user to bite down on the therapeutic oral appliance 1800 without requiring a fitting over teeth. This may allow for a more universal fit, such as for over-the-counter solutions.

For example, the teeth caps may enclose three teeth separately on both sides of the mouth to ensure the required stability and security for the therapeutic oral appliance 1800. In some implementations, a mold may provide a mated fit between the hard palate portion 1830 and the hard palate within the oral cavity. In some aspects, the hard palate portion 1830 may comprise a variety of materials to accommodate a plurality of preferences. As an example, the therapeutic oral appliance 1800 may comprise silicone for ideal softness, durability, and hygiene.

In some embodiments, the therapeutic oral appliance may comprise a soft silicone material with low shore hardness. This may provide an airway 1815 channel for breathing that allows for flexibility. The flexibility may allow the patient to swallow and maintain some tongue movement. This allowance may increase comfort for the patient. In some implementations, the mouth guard portion 1820 may cover one or more teeth or gums as a means to protect teeth from pressure points from the oral airway. The mouth guard portion 1820 may stabilize the oral airway while the user is unconscious to reduce the chance of inadvertent rejection by spitting out the therapeutic oral appliance 1800.

For example, a user's hard palate may be prone to inflammation when interfacing with typical medical grade plastics and polymers. The user may experience greater comfort and utility by utilizing a therapeutic oral appliance 1800 that comprises a hard palate portion 1830 composed of a metal or silicone mesh. A flexible or meshed hard palate portion 1830 may allow for a snug fit without requiring a custom mold.

Referring now to FIG. 19, an exemplary adjustable therapeutic oral appliance 1900 is illustrated. In some embodiments, the mouth guard portion 1920 may comprise a plurality of components. In some implementations, the dimensions of the therapeutic oral appliance 1900 may be adjustable. In some aspects, the tongue retainer portion 1910 may attach to a frame of the therapeutic oral appliance 1900. In some embodiments, the hard palate portion 1930 may interface with a minimized region of the hard palate.

In some implementations, a mouth may be changing and growing quickly, such as with children. Their mouth size and shape may change between incremental tongue retainer portions 1910, which may make it impractical to use one mouth mold to create the incremental therapeutic oral appliances 1900. In some aspects, a mouth guard portion 1920 may fit over a few teeth, such as front teeth and back molars, that are unlikely to shift or change drastically during the acclimation period for the therapeutic oral appliance 1900. This may be combined with an extendable hard palate portion 1930 that may allow for growth.

Referring now to FIG. 20, an exemplary therapeutic oral appliance 2000 configured to interface with one or more dental fixtures, such as by being attachable thereto, is illustrated. In some aspects, the dental fixtures may be attached to the teeth 2050. For example, the therapeutic oral appliance 2000 may connect to the metal fastening rods located on braces 2055 that are secured to the teeth 2050. For example, a teenager may overcome sleep apnea while wearing braces by attaching the therapeutic oral appliance 2000 to hooks on braces attached to the canine teeth. In some embodiments, the mouth guard portion 2020 may extend rearward into the mouth. In some implementations, the hard palate portion 2030 may interface with a minimized region of the hard palate.

Referring now to FIG. 21, an exemplary therapeutic oral appliance 2100 with wireless data transmission capabilities is illustrated. In some embodiments, the therapeutic oral appliance may contain a plurality of electronic components that may be configured to interface with at least one external device 2190. In some implementations, the therapeutic oral appliance 2100 may be configured to interface with and relay information to at least one wearable device 2195 (such as, for example and not limitation, a smart watch). In some aspects, the tongue retainer portion 2110 may comprise a one or more sensors.

In some embodiments, the airway 2115 may contain a plurality of electronic components. For example, the therapeutic oral appliance 2100 may comprise electrodes that may provide transcutaneous electrical stimulation to oropharyngeal and tongue muscles. This may increase muscle tone, allowing for an opening of the patient airway channel.

For example, a child prone to seizures may use a therapeutic oral appliance 2100 with an embedded accelerometer that notifies the parents of shape increases in rapid movement that may be indicative of a seizure. This may be helpful at night when the family is asleep and the parents may otherwise remain unaware of the child's seizure. The therapeutic oral appliance 2100 may limit likelihood that a seizure may cause the tongue to obstruct the child's airway, which may cause permanent or temporary brain damage.

As another example, a user may purchase a therapeutic oral appliance 2100 to overcome sleep apnea that pairs with an external device 2190 in the form of the user's phone (such as, for example and not limitation, a smartphone) or computing device, such as a desktop computer, a laptop computer, or tablet as non-limiting examples. Embedded accelerometers and heart rate monitors may record information as the user sleeps to display quality of sleep information. The user may be able to see how restless they slept as well as their rest heart rate and oxygen levels. This may assist in overcoming sleep apnea by emitting vibrational frequencies during sleep to reposition the user to a better sleeping position when oxygen levels are too low.

As another example, a user may be recovering from an illness that has a high rate of respiratory issues. The therapeutic oral appliance 2100 may track oxygenation levels (for example, by using a pulse oximeter) and heart rate to monitor and manage symptoms. Where levels drop below predefined threshold parameters, a practitioner or hospital may be notified. If a user is unresponsive to the practitioner, an ambulance may be sent.

As an illustrative example, an anesthesiologist may insert a therapeutic oral appliance 2100 during a surgery that comprises one or more health monitors. The anesthesiologist may monitor heart rate, oxygen levels, and breathing rate during the surgery. This information may display via Bluetooth connection with one or more external devices 2190 in the form of one or more medical apparatuses stationed within the operation room. The medical equipment may be configured to convey notifications and alarms for predetermined thresholds. The medical equipment may notify the anesthesiologist of recommended times to routinely evaluate specific health criterion based on current health levels of the patient.

As another illustrative example, the therapeutic oral appliance 2100 may comprise a capnograph or gas analyzer. A capnograph may measure predefined gases, such as inhaled oxygen and expired carbon dioxide. A gas analyzer may indicate how much oxygen therapy may be required to achieve a desired blood oxygen saturation. The gas monitors may provide indicative information regarding a patient's ventilation. Audible and visual indicators may notify the healthcare professional if there is obstruction or hypercarbic symptoms due to OSA or poor ventilation.

Referring now to FIGS. 22A-22B, a process 2200 of forming an exemplary therapeutic oral appliance is illustrated. In some embodiments, therapeutic oral appliance may be formed from an impression. In some implementations, the impression may comprise an impression of teeth and an impression of the hard palate, as non-limiting options. For example, physical impressions may be made of the upper hard palate, dentition, and as much of the soft palate as can be tolerated.

In some aspects, the impressions of the patient's mouth may be rendered digitally. As an example, an impression may be scanned by a high-fidelity 3-D scanner to render a virtual representation of the impression within a modeling software. In some embodiments, a digital rendering of an airway may be created along the longitudinal length of the digital impression of the therapeutic oral appliance. In some implementations, a physical construction of the digital rendering and airway may be formed. For example, the digital rendering may be printed by a 3-D printer. In some embodiments, this physical construction may provide a tangible medium to further the formation of the therapeutic oral appliance, such as by providing a shape for a mold.

In some aspects, a mold may be formed using the physical rendition of the impression and the airway. In some embodiments, the mold may be used to create a therapeutic oral appliance by using the mold for casting. For example, a 3-D printed prototype may be place in casting clay to form an impression that is subsequently filled with a soft silicone material. As another example, a synthetic polymer may be poured into the mold and, upon solidifying, may produce a therapeutic oral appliance in the form of the impression and the airway.

Referring now to FIG. 23, a method 2300 of forming an exemplary therapeutic oral appliance is illustrated. At 2305, physical impressions of a patient's mouth may be formed. In some embodiments, the impressions may comprise an impression of the teeth and an impression of the hard palate, as non-limiting options. At 2310, the impressions of the patient's mouth may be scanned in three dimensions. As an example, an impression may be scanned by a high-fidelity 3-D scanner to render a virtual representation of the impression within a modeling software.

At 2315, a digital rendering of an airway may be created along the longitudinal length of the digital impression. At 2320, a physical construction of the digital impression and airway may be constructed. For example, the digital rendering of the impression and the airway may be printed by a 3-D printer.

At 2325, a mold may be formed using the physical rendition of the impression and the airway. At 2330, the mold may be used to create a therapeutic oral appliance by using the mold for casting. For example, a synthetic polymer may be poured into the mold and, upon solidifying, may produce a therapeutic oral appliance in the form of the impression and the airway.

CONCLUSION

A number of embodiments of the present disclosure have been described. While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any disclosures or of what may be claimed, but rather as descriptions of features specific to particular embodiments of the present disclosure.

Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination or in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in combination in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.

Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous.

Moreover, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products.

Thus, particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. In addition, the processes depicted in the accompanying figures do not necessarily require the particular order show, or sequential order, to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the claimed disclosure. 

What is claimed is:
 1. A therapeutic oral appliance comprising: a mouth guard portion, wherein the mouth guard portion is configured to at least partially interface with one or more teeth of a user; a hard palate portion configured to at least partially interface with a hard palate of a mouth of the user, wherein the hard palate portion extends upward from the mouth guard portion; a tongue retainer portion, wherein the tongue retainer portion extends from the hard palate portion into at least a portion of a throat of the user, wherein the tongue retainer portion comprises an upper surface, a lower surface, and a longitudinal length; and an airway, wherein the airway comprises one or more recesses within at least one of: the upper surface of the tongue retainer portion and the lower surface of the tongue retainer portion, wherein the airway extends along at least a portion of the longitudinal length of the tongue retainer portion.
 2. The therapeutic oral appliance of claim 1, wherein the mouth guard portion comprises at least one safety mechanism.
 3. The therapeutic oral appliance of claim 1, wherein the tongue retainer portion is fixed to a distal end of the hard palate portion.
 4. The therapeutic oral appliance of claim 1, wherein the longitudinal length of the tongue retainer portion is adjustable.
 5. The therapeutic oral appliance of claim 1, wherein the mouth guard portion comprises at least one external attachment configured to interface with at least one supplemental device.
 6. The therapeutic oral appliance of claim 5, wherein the at least one external attachment comprises at least one aperture.
 7. The therapeutic oral appliance of claim 6, wherein the at least one supplemental device comprises a tube.
 8. The therapeutic oral appliance of claim 1, wherein the mouth guard portion comprises a universal fit that may be used by a generic user.
 9. The therapeutic oral appliance of claim 1, wherein the mouth guard portion is configured to interface with one or more dental fixtures.
 10. The therapeutic oral appliance of claim 9, wherein the one or more dental fixtures comprise braces.
 11. The therapeutic oral appliance of claim 1, wherein the therapeutic oral appliance further comprises one or more sensors.
 12. The therapeutic oral appliance of claim 11, wherein the one or more sensors comprise at least one of: an accelerometer, a heart rate monitor, a pulse oximeter, and a capnograph.
 13. The therapeutic oral appliance of claim 11, wherein the therapeutic oral appliance is configured to interface with at least one external device.
 14. The therapeutic oral appliance of claim 13, wherein the at least one external device comprises at one of: a smartphone, a desktop computer, a laptop computer, a tablet, and a medical apparatus.
 15. The therapeutic oral appliance of claim 8, wherein the therapeutic oral appliance is configured to interface with at least one wearable device.
 16. The therapeutic oral appliance of claim 15, wherein the at least one wearable device comprises a smart watch.
 17. The therapeutic oral appliance of claim 1, wherein the mouth guard portion comprises at least one wire.
 18. The therapeutic oral appliance of claim 1, wherein the mouth guard portion comprises an at least partially customized fit for a specific user.
 19. The therapeutic oral appliance of claim 1, wherein the mouth guard portion is adjustable.
 20. The therapeutic oral appliance of claim 1, wherein the hard palate portion extends upward from the mouth guard portion to a point of central convergence. 